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FDA 510(k)

JFord Speculum Sleeve™

K-Number: K252208 · 2026-03-06

ApplicantFord Medtech, LLC
Decision Date2026-03-06
Product CodeHIB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

JFord Speculum Sleeve™ is a medical device manufactured by Ford Medtech, LLC. It received FDA 510(k) clearance on 2026-03-06 under approval number K252208. The device is classified under product code HIB. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JFord Speculum Sleeve™?

JFord Speculum Sleeve™ is a medical device that received FDA 510(k) clearance on 2026-03-06. It is manufactured by Ford Medtech, LLC. The 510(k) number is K252208.

When was JFord Speculum Sleeve™ approved by the FDA?

JFord Speculum Sleeve™ received FDA 510(k) clearance on 2026-03-06, under approval number K252208.

What company makes JFord Speculum Sleeve™?

JFord Speculum Sleeve™ is manufactured by Ford Medtech, LLC.

What is the FDA product code for JFord Speculum Sleeve™?

The FDA product code for JFord Speculum Sleeve™ is HIB.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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